Kornimate/medical-research-clean huggingface dataset:
preventive physiotherapy intervention in elderly people with sarcopenia

Conditions: Sarcopenia; Syndrome; Institutionalization

Summary: this study evaluates two strength training protocols (one in peripheral muscles and one in inspiratory muscles) in the improvement of skeletal muscle mass and function in institutionalized elderly with sarcopenia. participants will be assigned randomly in a control or one of both experimental groups.

sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life and death (goodpaster et al, 2006; delmonico et al, 2007). the contributing factors are those related to aging process, non-optimal diet, bed rest or sedentary lifestyle, chronic diseases and certain drug treatments. most of these factors are present in the older population with comorbidity, frequently institutionalized to receive a professional long-term care. since the european working group on sarcopenia in older people (cruz-jentoft et al, 2010) recommends using the presence of both low muscle mass and low muscle function (strength and/or physical performance) for the diagnosis of sarcopenia, interventions should be focused in both criteria. the aim of this study is to prevent loss of skeletal muscle mass and strength in institutionalized elderly with sarcopenia. to this purpose, the investigators study undertakes two physiotherapy interventions to preventing/treating sarcopenia, namely, maintenance of muscle mass and improvement of strength in peripheral and respiratory muscles. both interventions are common in the following features: supervision, duration, frequency and intensity of the training program. the primary outcomes are those related to muscle mass and strength. secondary outcomes will be related to muscle function (muscle endurance and/or physical performance), costs and health status (number of falls and fractures, exacerbations of chronic diseases, hospitalizations and deaths during the year after concluding the physiotherapy interventions).

Eligibility criteria:
inclusion criteria: * people aged \> 65 years * sarcopenia diagnosis (tyrovolas et al., 2015) * medically stable at least 2 months before the study exclusion criteria: * cardiorespiratory, muscular, neurological, or neuromuscular disease that could interfere in the proper performance of assessment and/or training protocols. * endocrine and metabolic disorders that might have had an effect on muscle mass. * severe disorder of hydration status that could interfere in bioelectrical impedance analysis (rubbieri et al., 2014). * a terminal disease diagnosis. * mini-mental state examination index ≤ 20 score.

Keywords: elderly institutionalization sarcopenia strength training muscle mass muscle strength physical performance
returning research results that indicate risk of alzheimer disease dementia to healthy participants in longitudinal studies

Conditions: Alzheimer Disease; Dementia of Alzheimer Type

Summary: this is a study to evaluate the impact of returning research results that indicate a five-year risk estimate of alzheimer disease dementia to participants without memory or thinking problems of the knight alzheimer disease research center at washington university in st. louis.

all participants without memory or thinking problems in a longitudinal observational cohort of aging (memory and aging project) will be offered a five-year alzheimer dementia risk estimate report that incorporates genetic and either neuroimaging research results or plasma amyloid results as well as demographic information into five-year alzheimer disease dementia risk estimate. using a two-year delayed-start randomized clinical trial design, participants will be randomized to receive research results either two weeks (arm a/c) or one year (arm b/d) after informed consent.

Eligibility criteria:
inclusion criteria: * current knight adrc participants who had their clinical assessment in the previous year. * minimum age of 65 years old * participant must be classified as cognitively normal (cdr® = 0) at their last clinical assessment. * participant has either recent research brain mri and amyloid pet scan results, or recent plasma amyloid measurements (ideally within the past two years, but up to five years will be acceptable due to covid-19-related delays). * participant has genetic research results available including apoe status. * participant is currently consented to be contacted for other research opportunities through the knight adrc. exclusion criteria: * there are no exclusion criteria, other than not meeting all of the inclusion criteria listed above.

Keywords: dementia alzheimer disease dementia genetics neuroimaging
energy flux and fat oxidation using low and high glycaemic index foods

Conditions: Type 2 Diabetes; Obesity; PreDiabetes

Summary: purpose: this study is carried out to determine the effect of gi on 24 hour blood glucose profiles and energy regulation in asians when fed a normal diet modulated with sweeteners.

the gi is a method of classifying foods based on the food's ability to raise the blood glucose level. low gi foods are recommended as they have a lower impact on blood glucose concentrations. the research sets out to determine the effect of gi on 24 hour blood glucose profiles and energy regulation in asians. healthy, normal-weight and overweight, chinese males will be recruited. there will be two sessions (consisting of three days for each session) where they will consume either a high or low glycaemic index dinner at home and a high or low gi breakfast, lunch and snack on the next day (in the whole body calorimeter). there will be at least five days in between the two sessions. their glycaemic response will be measured using a continuous glucose monitoring system (cgms) throughout the period, while substrate oxidation will be measured over 10 hours in the calorimeter (from breakfast, lunch and snack). this study specifically attempts to see whether the inclusion of a low gi sweetener in a mixed meal sequence can impact blood glucose levels and energy regulation in asians. the study is important in that it will enable us to compute the rate of fat oxidation and how it is influenced when subjects are fed a mixed meals modulated to be high gi (increased glucose excursions) or low gi (moderated glucose) over 24 hours in healthy asians. obesity and diabetes rates are increasing exponentially in asian populations and singapore is no exception. devising ways and means to staunch the escalation is therefore a priority. the findings of the research will contribute towards the long-term objectives of developing dietary guidelines for weight and glycaemic control. the study data will also be important for the provision of practical food-based advocacy for better weight and glycaemic control in asians.

Eligibility criteria:
inclusion criteria: * chinese, male * age between 21-40 years * body mass index between 17 to 28 kg/m2 * normal blood pressure (\<140/80 hgmm) * fasting blood glucose \< 6 mmol/l exclusion criteria: * having any metabolic diseases (such as diabetes, hypertension etc) * one prescription medication * partaking in sports at the competitive and/or endurance levels * allergic/intolerant to any of the test foods * intentionally restricting food intake * smoking
local surgery for metastatic breast cancer

Conditions: Breast Cancer

Summary: primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. we hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival

this is a randomised, controled clinical trial. our aim is to observe whether primary surgery improves survival in metastatic breast cancer. women who have metastatic breast cancer at the initial diagnosis will be included in the study. there will be two study arms: primary surgery and systemic chemotherapy groups. in the primary surgery group patients will have adjuvant therapies after they had the proper surgery. in the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). during the follow-up period, patients will be seen in every 6 months.

Eligibility criteria:
inclusion criteria: * women with metastatic breast cancer at the initial diagnosis exclusion criteria: * women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc) * who have systemic morbidity that do not allows her to be in the trial, * who have synchronous breast cancer at the contralateral breast, * who have a previous cancer history or another primary cancer history and metastasis at the past, * who have palpable lymph node/nodes at the contralateral axilla, * who do not agree to participate the trial

Keywords: 1-metastatic breast cancer 2-surgery 3-survival
diabetes and travel: evaluation of a diabetes education module - a randomized controlled trial (primo_travel)

Conditions: Diabetes Mellitus

Summary: this study is a multi-center, randomized prospective trial with a 6-month follow up. a newly developed treatment and education module will be tested compared to a waiting-list control group. the module covers the topic "diabetes and travel". primary outcome variable is diabetes-specific empowerment regarding diabetes and travel. secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.

the module consists of one lesson (duration: 90 minutes). the module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: primas (nct01220557). the module is designed as a group session held by a trained diabetes educator. patients are randomized either to the immediate participation in the module or to the control group. control group is a waiting-list control group. patients in this waiting-list control group get the education after the completion of the 6-month follow-up.

Eligibility criteria:
inclusion criteria: * intensive insulin treatment * specific interest in "diabetes and travel" * wish to participate in group education * informed consent * fluent in reading and speaking german language exclusion criteria: * diabetes duration \< 4 week * severe organic disease (e.g. terminal renal disease, cancer with poor prognosis) * current treatment of a mental disease * cognitive impairment * dementia * pregnancy

Keywords: diabetes education randomized prospective
a follow-up survey to compare stable dosing (seretide) with symbicort, smart, maintenance and reliever therapy in one inhaler in moderate and severe asthmatics.

Conditions: Asthma

Summary: the purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies, regular treatment with seretide in a stable dosing with short acting beta-2 agonists as needed, or maintenance treatment with symbicort and using the same inhaler with symbicort as needed.

the purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies. no therapy intervention is made with existing prescribed medications (seretide or symbicort), but evaluations outside standard care is made by evluations with diary cards, questionnaires, pef evaluations and spirometry which is regarded as the intervention by the swedish authorities.

Eligibility criteria:
inclusion criteria: * written informed consent * 18 years or above * able to fill in questionnaires and perform pef measurements * asthma diagnosis and prescribed seretide or symbicort, either regular treatment using seretide in a stable dosing and short acting b2 agonists as needed, or maintenance treatment with symbicort but also using same inhaler symbicort as needed exclusion criteria: * no other lung disease * neurological disease with psychological handicap * cerebro-vascular disease with handicap * un-stable cancer * known or planned pregnancy during the time of the study * subjects who have serious uncontrolled disease
specimen collection study protocol

Conditions: Focus in on Collecting Paired Specimens for Matrix Equivalency

Summary: the specimens collected will be used to evaluate matrix equivalency in an immunoassay in development for the detection of igg or iga or igm antibodies to sars - cov2 in human serum. these reagents are for in vitro diagnostic use only.

the objective of this study is to acquire paired serum, plasma and whole blood collected on a collection card from subjects with no known history of covid-19 infection. the specimens will be collected at biomerica in irvine ca for specimen collection, banking, and matrix equivalency studies for projects in development at biomerica for detection to igg or iga or igm antibodies to sars-cov2 antibodies. subject will also be asked to self-collect a nasal swab for covid-19 pcr

Eligibility criteria:
inclusion criteria: * aged 21 and older * able to read, speak, and understand english * must weigh a minimum of 110 pounds * willing and able to donate 20 mls of whole blood via venipuncture. \[approximately ˂ 2 tablespoons\] * willing and able to donate 0.040 mls of whole blood via fingerstick * willing and able to sign the informed consent (self or authorized representative) * willing and able to self-collect a nasal swab per the provided instruction shee exclusion criteria: * aged less than 21 years old * unable to provide consent. * unable to donate blood via venipuncture and fingerstick. * unable to self-collect a nasal swab
study of pf-04523655 (redd14np) in subjects with choroidal neovascularization (cnv) secondary to age-related macular degeneration (wet amd)

Conditions: Age-Related Macular Degeneration

Summary: the aim of the study is to evaluate whether pf-04523655 is safe in the treatment of neovascular/wet amd

dose escalation safety study

Eligibility criteria:
inclusion criteria: * patient is ≥ 50 years old and in general good health. patients with medically controlled chronic disease such as htn, aodm, and hyperlipidemia may be included. * patient is capable of giving consent. * patient is willing and able to comply with the visit schedule and study procedures including follow-up visits. * patient has documented cnv secondary to amd with evidence of active disease characterized by blood vessel leakage or evidence of hemorrhage. * patient has clear ocular media and adequate pupil dilation to allow good quality imaging by fundus photography. * patient's intraocular pressure is ≤ 25 mmhg exclusion criteria: * patient is of childbearing potential. every female patient is considered of child-bearing potential unless she has had sterilization surgery or is post-menopausal and has not had a menstrual period for at least 12 months. * patient has cnv due to causes other than amd, including ocular or periocular infections. * patient has lesions not easily imaged and quantified. * patient has underlying systemic disease such as cardiac, neurological, infectious disease, uncontrolled diabetes mellitis, or disease of the eye other than amd. patient may have medically controlled glaucoma. * patient is participating in any concurrent interventional study.

Keywords: choroidal neovascularization (cnv) "wet" amd
airway redox and gender determinants in severe asthma

Conditions: Asthma

Summary: the investigators will study the biologic and chemical differences that cause the greater incidence, and severity of asthma in women as compared to men. severe asthma affects boys more than girls, while severe asthma in adults is predominantly a disease of women. the investigators aim to identify the processes that occur in the body that are behind the onset of severe asthma in young women during the teenage years, and the resolution of severe asthma in boys. to further evaluate gender influences on asthma, asthmatic women at different stages of their menstrual cycle (period) will be also studied. the investigators aim to use biomarkers to develop testing procedures that will identify different types or characteristics of asthma in men and women; and to follow patients over time to uncover relevant clinical outcomes of biomarkers. the investigators anticipate that they will 1) develop clinically relevant tests to identify unique types or characteristics of asthma and severe asthma; 2) determine outcomes over time of biochemically-defined types of asthma; and 3) identify the reasons for why adult women are affected more than men with severe asthma.

this scientific site-specific project is part of a larger network of asthma studies, the severe asthma research program (sarp). the mission of sarp is to improve the understanding of severe asthma to develop better treatments.

Eligibility criteria:
inclusion criteria: subjects with asthma * children age 6-17 years old (25% enrollment) * adults 18 years and older (75% enrollment) exclusion criteria: * pregnancy during the characterization phase * current smoking * smoking history \> 10 pack years if ≥30 years of age, or smoking history \> 5 pack years if \<30 years of age (note: if a subject has a smoking history, no smoking within the past year), * other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the pi's discretion) * severe scoliosis or chest wall deformities * history of premature birth before 35 weeks gestation * unwillingness to receive an intramuscular triamcinolone acetonide injection.

Keywords: asthma biomakers phenotype
a study of islatravir (mk-8591) in trans and gender diverse participants (mk-8591-035)

Conditions: Human Immunodeficiency Virus (HIV) Infections

Summary: the primary objective of this study is to evaluate the safety and tolerability of islatravir (isl) in trans and gender diverse (tgd) participants who are receiving gender-affirming hormone therapy (gaht) and are at low-risk for human immunodeficiency virus 1 (hiv-1) infection.


Eligibility criteria:
inclusion criteria: * is confirmed hiv-uninfected based on negative hiv-1/hiv-2 test result before allocation to study intervention. * is on stable gaht and does not intend to change therapy through week 4 of the study. * has a low-risk of hiv infection. * identifies with a gender that is different from that assigned at birth. * a participant assigned female at birth is eligible if not pregnant or chest-feeding and is not of childbearing potential (pocbp) or: is a pocbp and using an acceptable contraceptive method, or be abstinent from penile-vaginal intercourse with an individual capable of producing sperm (abstinent on a long term and persistent basis); a pocbp must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g, an ambiguous result), a serum pregnancy test is required. in such cases, the participant must be excluded from participation if the serum pregnancy result is positive; the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant assigned female at birth with an early undetected pregnancy; contraceptive use by participant assigned female at birth should be consistent with local regulations. exclusion criteria: * has known current or chronic history of liver disease (e.g, non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome, asymptomatic gallstones, or cholecystectomy), unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction. * has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ anal cancers. * has taken cabotegravir, lenacapavir, or any other long-acting hiv prevention product at any time (past or current use). * is currently participating in or has participated in a clinical study with an investigational compound or device, within 30 days before day 1 through the duration of the study. * is expecting to conceive or donate eggs at any time during the study.
achieving energy balance in post partum teens

Conditions: Obesity

Summary: this proposal will test balance adolescent lifestyle activities and nutrition choices for energy (balance), a multilevel intervention administered through parents as teachers (pat) and designed to reduce overweight in postpartum teens. the intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).


Eligibility criteria:
inclusion criteria: * between 12 to 20 years of age * less than 1 year post partum * current participant in parents as teachers exclusion criteria: * currently pregnant